Sartorius Stedim Biotech has entered into an agreement with WuXi AppTec, Inc., a subsidiary of WuXi PharmaTech, to work on viral clearance studies. Under this agreement, WuXi AppTec will provide the relevant viruses, materials and methodologies to Sartorius Stedim Biotech to employ in conducting non-GLP viral clearance testing of its technologies with customer products and for supporting its own R&D activities.
    
Sartorius Stedim Biotech markets an orthogonal and integrated three-step viral clearance technology platform to the biopharmaceutical industry. To support its customers and to meet regulatory expectations, the company has built an in-house lab for non-GLP viral clearance testing of its technologies.
   
The non-GLP viral clearance testing during early-stage process development will allow Sartorius to recommend the best viral clearance technology option. Sartorius and WuXi AppTec will be using the same viruses, materials and methodologies so that customers can anticipate predictive study results of what might be expected from WuXi AppTec´s GLP Viral Clearance testing of the same product as part of the IND process and eventually the Phase III validation process.
   
“Viral clearance studies are gaining more importance at early stage process development and with WuXi AppTec we have found an excellent partner to realize both early stage non-GLP testing at Sartorius and GLP testing at WuXi AppTec,” said Reinhard Vogt, vice chief executive officer sales and marketing and member of the board of Sartorius Stedim Biotech.
   
“We are very pleased to be able to partner with Sartorius Stedim Biotech in offering this unique benefit for biopharmaceutical manufacturers,” said WuXi AppTec vice president Larry Thomas. “It is a perfect fit with our company’s commitment to providing clients with seamless single-source solutions to help shorten the time from initial process development to a successful IND.”